The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that as from 30 March 2019, 00:00h (CET (‘the withdrawal date’)1 the United Kingdom will be a ‘third country’2.
Preparing for the withdrawal is not just a matter for EU and national authorities, but also for private parties. In view of the uncertainties surrounding the ratification of the Withdrawal Agreement, all interested parties, and especially economic operators, are reminded of legal repercussions, which need to be considered when the United Kingdom becomes a third country.
Subject to the transition period provided for in the draft Withdrawal Agreement3, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. This has, in particular, the following consequences in the different areas of EU law on medicinal products:
- EU law requires that marketing authorisation holders are established in the EU (or EEA);
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.
Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human use within the European Union.
In particular, the CMDh expects marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.
The CMDh has provided detailed Q&As and additional in formation on the website of the CMDh, which is continuously updated.
For products authorised in the centralised procedure the information will be provided through the websites of the Commission and the European Medicines Agency. These pages will be updated with further information, where necessary.